Changzhou SynTheAll Pharmaceutical Co., Ltd
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- China
- Registered address
- No.589, North Yulong Road, Xinbei District, Changzhou, 213127, China (CHN)
- Operations here
- analysisapi manufacturemanufacture
- FDA identifiers
- FEI 3012897823 · DUNS 544385021
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2025-03-07
- NAIDrug Quality Assurance2019-07-19
Drugs this plant is listed as making
5 distinct drugs across 8 products name this site in their FDA label.
- NIRAPARIB TOSYLATE MONOHYDRATE and ABIRATERONE ACETATEJanssen Biotech, Inc.
- TovorafenibDay One Biopharmaceuticals, Inc.
- VadadustatAkebia Therapeutics, Inc.
- ziftomenibKura Oncology, Inc.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.